EP3628365B1 - Connection device for wound care and wound care kit - Google Patents

Description

The invention relates to a device for connecting two lines each having an exudate lumen and at least one ventilation lumen for the medical field according to the preamble of patent claim 1.

In negative pressure therapy, negative pressure is generated in the area of a wound to be treated in order to promote the wound healing process. For this purpose, the wound region is connected to a corresponding pump via a usually tubular line, with which exudate can be sucked out of the wound region at the same time. In addition, it is regularly necessary to measure the pressure in the wound region via a separate line lumen, to ventilate the wound region via a separate line lumen, to supply wound cleaning agents, medication or the like, etc..

For individual indications, it can be advantageous to maintain a continuous flow in the area of the wound. For other indications, it may be useful to maintain a constant negative pressure. Finally, for some indications it also makes sense to generate and then reduce the negative pressure in a predetermined time sequence, i. H. apply an intermittent negative pressure in the area of the wound region. It has proven to be advantageous if two, three or more ventilation lumens of the multi-lumen line are used for ventilation, while the negative pressure can be generated via a line lumen with a larger line cross-section, referred to below as the exudate lumen.

For the purpose of negative pressure therapy, the line lumens must be connected to a suitable negative pressure therapy device. It is important to ensure that the connection is secure on the one hand, and that it can be opened manually if necessary, easily, quickly and easily on the other.

With the negative pressure therapy device, on the one hand, the negative pressure is generated and, on the other hand, ventilation or aeration and/or pressure measurement of the wound region and/or other of the tasks described above are carried out. In addition, in many cases it is necessary to connect two, three or more multi-lumen lines to one another if, for example, the position of the negative pressure therapy device changes in relation to the patient and/or the length of the line has to be adjusted accordingly. Existing lines can continue to be used if extension lines are fitted with suitable ones devices to be connected close to it. In addition, in many cases a plurality of wounds are treated using only one negative-pressure therapy device, in that the ventilation lumen and exudate lumen of the corresponding lines are connected to a common negative-pressure therapy device via a common connecting device.

It is known in the prior art to implement multi-lumen lines in the form of hoses through which several lumens pass in the axial direction. In this case it is no longer necessary to connect individual hoses to one another. Rather, it is sufficient if a multi-lumen hose is connected. In these known multi-lumen tubes, a central exudate lumen can be provided which runs coaxially to the tube axis. Ventilation lumens of the tube can be arranged radially offset and pass through the tube jacket delimiting the exudate lumen in the axial direction parallel to the tube axis.

An odd number of ventilation lumens is particularly advantageous, particularly preferably three ventilation lumens. The radially offset ventilation lumens can be equipped with a smaller cross-section than the central exudate lumen.

Connecting devices of the type mentioned, with which the connection and the connection of corresponding multi-lumen hoses are facilitated in the EP 3 117 868 A1 specified. The disclosure content of this document with regard to the construction of suitable connecting or connecting devices with suitable connecting or connecting pieces, sealing sleeves, chamber sleeves and clamping sleeves is hereby incorporated into this description by express reference.

Devices according to the preamble of claim 1 are specified in the U.S. 2008/011368 A1 , the EP 3117868 A1 and the GB 2356148A .

In particular when using the known connecting devices for treating two, three or more wounds using only one common negative pressure therapy device, it has been shown that therapy fails in some cases.

In view of these problems in the prior art, the invention is based on the object of providing a further development of the known connection or connecting devices with which therapy failure in the area of individual wounds can be reliably ruled out.

According to the invention, this object is achieved by the development of the known devices specified in the characterizing part of patent claim 1 .

The invention is based on the finding that when two, three or more wounds are treated using only one negative pressure therapy device, exudate flows between the individual wounds via the ventilation channels or ventilation lumens can. This is possible, for example, when there is a complete occlusion (blockage) in an exudate lumen and/or an exudate channel. Depending on the negative pressure conditions in the area of the individual wounds, an unwanted flow of exudate from one wound to the other can then occur via the ventilation lumen of the system.

For the treatment of two, three or more wounds using only one negative pressure therapy device, the connection device according to the invention is preferably designed in such a way that each wound is assigned a ventilation channel, so that all wounds can be ventilated using only one connection device and only one negative pressure therapy device. In the context of the invention, it has proven to be particularly advantageous if the barrier device is designed in such a way that when exudate enters a ventilation channel that leads to a wound, the passage of the exudate or other liquids into such ventilation channel sections is prevented lead to other wounds.

With the connection devices developed according to the invention, this flow of exudate is counteracted with the aid of a barrier device assigned to at least one ventilation channel. This can prevent an exchange of exudate fluids between the individual wounds and a therapy failure that can be attributed to this.

According to the invention, the barrier device has or consists of a preferably gas-permeable barrier element arranged in the ventilation duct. The gas permeability ensures the functional reliability of the connecting device during normal operation. The desired suppression of the passage of liquids through the ventilation channel can be ensured if the barrier element swells on contact with liquid and thus counteracts the passage of liquid through the ventilation channel.

For this purpose, the barrier element can have a super absorber. A barrier element that is simultaneously gas-permeable but on the other hand swellable can be provided by adding a superabsorbent powder to an open-pore foam, with the superabsorbent powder swelling on contact with liquid and assuming a gel-like state.

In the context of the invention, it has also proven to be advantageous if the barrier element is fitted precisely into the ventilation channel and closes it by swelling when it comes into contact with liquid. When dry, superabsorbents or open-pored foams containing superabsorbents are permeable to air and therefore do not affect the active ventilation of the wounds. Overall, the function of the overall arrangement can be ensured without treatment failure caused by an undesired flow of exudate through the ventilation lumen.

The exudate channel of a connecting device according to the invention is preferably at least partially delimited by at least one connecting piece onto which a multi-lumen tube forming the multi-lumen line can be pushed.

In the embodiment of the invention just described, the ventilation channel can be formed radially outside the connecting piece, preferably delimited at least in sections by a chamber sleeve that at least partially surrounds the connecting piece, the barrier element preferably being arranged between the connecting piece and the chamber sleeve. With this arrangement, a multi-lumen hose can be inserted into the annular gap between the connecting piece and the chamber sleeve. The ventilation lumens of the multi-lumen hose formed in the hose jacket then open into this annular gap, which defines the ventilation channel. Adjacent to an end face of the multi-lumen tube, the barrier element can be inserted in a form-fitting manner into the annular gap between the connecting piece and the chamber sleeve and preferably completely surround the connecting piece surrounded by the chamber sleeve.

The connecting device can have two, three or more connecting pieces that are connected to one another in a fluid-conducting manner, each of which is surrounded by a chamber sleeve and each of the connecting pieces can be connected to a wound care arrangement via a suitable multi-lumen hose in order to ensure the desired vacuum therapy in the area of several wounds.

Similar to connection or connection devices according to EP 3 117 868 A1 the connecting pieces can be formed by a common base body, which is designed to provide a distribution chamber for at least one ventilation lumen of the connected multi-lumen line opening therein, with preferably at least one ventilation channel being provided for removing or introducing a fluid from or into the distribution chamber and when the line is connected, the distribution chamber is sealed in a fluid-tight manner with respect to at least one exudate lumen in such a way that fluid exchange between the distribution chamber and this line lumen is prevented.

The individual multi-lumen hoses pushed onto the connecting pieces of the connecting device according to the connection can be connected to a common negative pressure therapy device if the connecting device has a connection area designed for connecting the exudate channel to a pump designed to generate a negative pressure and/or for connecting a ventilation device to the ventilation channel.

The connection area can have a connection piece, which is preferably at least partially surrounded by a connection sleeve and is connected to at least one connection piece in a fluid-conducting manner, onto which a multi-lumen line can be pushed, which can be connected to the negative pressure therapy device in the area of its end facing away from the connection device. Similar to the connecting piece, the connecting sleeve can also be at least partially surrounded by a connecting sleeve, the multi-lumen hose used to connect to the negative pressure therapy device can be inserted into an annular gap between the connecting piece and the connecting sleeve, wherein the annular gap can be fluidly connected to the ventilation channel into which the barrier element is inserted.

If the connecting device has two connecting pieces, the connecting pieces and the connecting piece can be arranged in an approximately Y-shape. In this case, each of the connecting pieces can be assigned a barrier element which preferably completely surrounds the corresponding connecting piece.

A treatment kit according to the invention has a connection device equipped according to the invention with a barrier device and a multi-lumen line that can be slid onto a connection piece or connection piece thereof.

The multi-lumen line preferably has a hose with a central exudate lumen delimited by a hose jacket and at least one ventilation lumen penetrating the hose jacket in a direction parallel to the hose axis and parallel to the exudate lumen, with the at least one ventilation lumen opening into the ventilation channel after connection to the connecting device and /or the connecting piece and/or connecting piece can be inserted into the exudate lumen.

The invention, to which reference is made with regard to all details essential to the invention and not expressly emphasized in the description, is explained below.

The single figure of the drawing shows a sectional view of a connecting device according to the invention. The connecting device 10 shown in the drawing comprises two connecting areas 20 and a connecting area 50 . The connecting pieces 22 are each surrounded by a connecting sleeve 24 , an annular gap being formed between the connecting piece 22 and the connecting sleeve 24 .

A sealing sleeve 26 is arranged in each of the individual annular gaps. Annular gaps are formed between the connecting piece 22 and the sealing sleeve 26, into which the hose jackets of multi-lumen hoses can be inserted, the connecting pieces 22 being inserted into a central exudate lumen of the multi-lumen hoses.

Ventilation lumens, which open into the annular gap, can pass through the hose jackets of the connecting hoses. The chamber sleeves 24 are surrounded by a clamping sleeve 28 which serves to lock the hoses pushed onto the connecting pieces 22 in the annular gaps formed between the chamber sleeves 24 and the connecting pieces 22 .

The connection area 50 is designed similarly. It also has a connecting piece 52 , a connecting sleeve 54 , a sealing sleeve 56 and a clamping sleeve 58 . The components of a connecting device according to the invention described so far correspond in structure and function to those in FIG EP 3 117 868 A1 described connection device. With regard to the structure and function of the connecting piece, connecting piece, connecting sleeve, connecting sleeve, sealing sleeve and clamping sleeve, reference is made to the disclosure content of this document.

A barrier element 30 is provided in the annular gap between the connecting piece 22 and the connecting sleeve 24 on the side of the sealing sleeve 26 facing away from the mouth area. The barrier element 30 is annular and gas-permeable overall. In the embodiment of the invention illustrated with reference to the drawing, the barrier element 30 is mixed with a super absorber which swells on contact with liquid.

If, depending on the negative pressure conditions, when an exudate lumen of a multi-lumen tube connected to a connecting area 20 is blocked, exudate liquid penetrates into the ventilation channel delimited between the connecting piece 22 and the connecting sleeve 24, there is contact between the exudate liquid and the barrier element 30. This leads to swelling of the barrier element 30. This prevents the flow of exudate through the aeration channel defined between the connecting piece 22 and the connecting sleeve 24.

The invention is not limited to the exemplary embodiment explained with reference to the drawing. Rather, the use of connecting devices with three, four or more connecting areas is also contemplated. Two, three or more connection areas can also be provided. A different Y-shaped arrangement than the one shown is also contemplated for connecting and connecting pieces. It is essential that a barrier element is arranged in a ventilation channel of the device, which swells on contact with liquid and prevents exudate from flowing through the ventilation channel.

Claims (8)

1. Device for connecting two lines adapted for the medical field, each having at least one exudate lumen and at least one ventilation lumen, and appropriate for wound care using negative pressure therapy, wherein the device comprises at least two fluid-conducting channels, of which at least one exudate channel is configured to be connected, in a fluid-conducting manner, to the exudate lumens of the multi-lumen lines and at least one ventilation channel is configured to be connected, in a fluid-conducting manner, to the ventilation lumens of the multi-lumen lines, wherein a barrier device (30) counteracting the passage of liquids is associated with at least one ventilation channel, characterised in that the barrier device includes or is a gas-permeable barrier element (30) arranged in the ventilation channel.
2. Device according to claim 1, characterised in that the barrier element (30) swells on contact with liquid and thus counteracts the passage of liquid through the ventilation channel.
3. Device according to claim 2, characterised in that the barrier element includes a super absorber.
4. Device according to one of the preceding claims, characterised in that the exudate channel is at least partially delimited by at least one connecting piece (22) onto which a multi-lumen tube forming the multi-lumen line can be pushed.
5. Device according to claim 4, characterised in that the ventilation channel is formed radially outside of the connecting piece, and is delimited preferably at least in sections by a chamber sleeve (24) which at least partially surrounds the connecting piece (22), wherein the barrier element (30) is preferably arranged between the connecting piece (22) and the chamber sleeve (24).
6. Device according to one of the preceding claims, characterised by a connection area (50) configured for the connection of the exudate channel to a pump configured to generate a negative pressure and/or for the connection of a ventilation device to the ventilation channel.
7. Device according to claim 6, characterised in that the connection area (50) has a connection piece (52) which is preferably at least partially surrounded by a connection sleeve (54) and which is connected in a fluid-conducting manner to the at least one connecting piece (22).
8. Device according to claim 7, comprising two connecting pieces (22), wherein said connecting pieces (22) and said connection piece (52) are arranged approximately in a Y-shape.

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